CN113164162A - 用于肺病的快速诊断的支气管内导管系统和方法 - Google Patents
用于肺病的快速诊断的支气管内导管系统和方法 Download PDFInfo
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- CN113164162A CN113164162A CN201980081027.9A CN201980081027A CN113164162A CN 113164162 A CN113164162 A CN 113164162A CN 201980081027 A CN201980081027 A CN 201980081027A CN 113164162 A CN113164162 A CN 113164162A
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Abstract
一种医疗装置及其使用方法,该医疗装置及其使用方法包括导管、至少两个电磁感应线圈和多元件平面超声波换能器阵列,所述至少两个电磁感应线圈位于导管的远侧尖端内,多元件平面超声波换能器阵列位于导管的远侧尖端内并且被配置成发射和接收超声波能量。该装置还包括耦接至超声波换能器的成像系统,并且成像系统用于创建第一目标平面内的组织的图像,第一目标平面从导管主体正交地延伸。医疗装置还包括用于接收和评估第一目标平面内的第二目标区内的组织的声谱特性的反向散射评估系统。
Description
相关案例的交叉引用
本申请是要求2018年12月7日提交的临时申请号62/776,677和62/776,667的优先权的实用申请,并且其全部内容通过引用并入本文。
技术领域
一种医疗装置导管系统,该医疗装置导管系统集成并向用户提供电磁导航/定位信息和超声成像以及频谱反向散射评估信息,以用于在患者的肺内使用以提供用于癌症诊断的多模式基础。导管系统可以经由支气管内通路装置递送至肺部。在评估后,可通过支气管内通路装置提供治疗,提供紧凑且有效的干预,将诊断和治疗两者结合在单个疗程中。尽管在肺癌治疗的上下文中公开,该方法也可用于其他肺部疾病。
背景技术
肺癌诊断的当前标准
目前常规的癌症方案要求收集在常规检查(X射线、CT)期间发现的疑似组织的物理样本(活检)。将活检样本送到实验室进行显微评估,并且实验室病理学家宣布样本的病理学以做出疾病的诊断。
接下来,患者和他的医师选择适当的治疗方案,其中可以包括在肺癌情况下的手术切除、化学疗法或消融。如果组织表现为晚期肺癌,则需要姑息治疗和临终关怀治疗。如果组织表现为慢性阻塞性肺病(COPD)或其他疾病,则将选择适当的治疗方案。如果组织是正常的,则不需要干预。
这种传统的诊断方法学发生在若干医疗干预期内,可能需要重复这些医疗干预期以验证疾病的诊断特征,这是不希望的。这种传统的方法学还具有低的诊断率。许多疾病病例被遗漏,特别是在早期肺部疾病中最容易治疗的时候。此外,偶尔地,误诊会导致不必要的干预。
用于评估肺部疾病的当前技术
对肺支气管镜检查的电磁导航(EM)的应用在20世纪90年代早期开始。Veran医疗技术公司(Veran Medical Technologies)已经开发了一组导管系统,其可与支气管镜一起使用或通过胸壁使用以准确地靶向并到达非常小的组织块。活检工具可以通过导管系统被递送至目标块,以收集组织的物理样本用于分析。
在标题为“内窥镜应用中的四维软组织导航的设备和方法”的美国专利8,696,549中详细描述了该技术。该文献通过引用并入本文。
通过简要概述,EM导航功能从索引到电磁导航系统的肺部的手术前CT扫描开始。肺部空间的模型通过时间被创建和跟踪,从而使得在计算模型空间内看到EM装置在身体内的位置。利用已知的EM传感器的实时位置或定位,可以执行计算以指示用于物理活检的装置的定位的准确位置。通常,术前计算机断层摄影X射线(CT)扫描用于建立患者体内的气道的导航模型。留置导管上的电磁传感器(EM)非常小,并且提供导管尖端在三维空间(3D)中的位置和定向信息。Veran系统还提供时变跟踪信息的第四维度。在Veran系统中可获得呼吸跟踪,并且这在改变探头在虚拟显示器中的视在位置以匹配EM传感器随着身体的呼吸运动而移动时的物理位置方面是有效的,这在本装置中非常有用。本发明中4D跟踪的益处是额外的精度,其允许重新进入位于肺部内的困难结构内的非常小体积的组织。
出于本发明的目的,在三维空间中转换已知位置并且将这个已知位置准确地参考到从CT或其他成像模态创建的图像空间中的能力允许在超声评估下精确地了解准确位置,并且允许物理活检和潜在治疗两者精确到同一位置,由此使得小结节是可治疗的。
目前,将超声成像应用于肺支气管镜仪器的公知装置由若干制造商提供。这些支气管内超声系统(EBUS)允许操作者看向气道外部。存在两种类型的EBUS。径向EBUS和线性EBUS。典型的视场有意地相当大并且相当深,以便尽可能的调查最大组织量。具有其解剖学细节的图像通常由医师用于导航。关注的目标仅由图像特征限定,并且由通过EBUS导管递送至目标点的活检工具访问。
常规超声的临床应用结合了许多成像模式,诸如,用于显示扫描平面中的回波幅度的灰度级“B模式”成像;用于随时间跟踪给定固定位置处的运动的M模式成像;用于在扫描平面中显示运动的双工、彩色和功率多普勒成像;用于显示对入射超声的非线性响应的谐波成像;用于显示相对组织硬度的弹性成像;以及使用造影试剂显示充满血液的空间或用目标试剂显示特定试剂结合组织类型的造影剂成像等。鲜为人知的超声技术被称为定量超声或(QUS),其分析作为从组织反向散射的接收到的回波信号中的功率分布随频率的变化。QUS利用得到的频谱参数来表征和区分组织。
发明内容
鉴于发明人,一组声学测量以及患者病史可以用于宣布组织样本癌变。预期该评估与常规病理评估一样准确,并且与常规病理评估相当。可以添加人工智能系统以组合来自若干来源的数据。例如,另一种潜在的成像技术涉及在CT和US成像管线的各个阶段应用AI技术(诸如卷积神经网络等)以基于训练数据集来表征组织。图像数据的这种AI辅助评估可加速总体诊断,这是理想的。
本发明的导管和相关系统允许在干预期间原位进入、识别和表征目标组织。该诊断数据全部在相同时间和在相同位置获取。该综合数据集可以与其他数据和常规医学判断结合以立即做出治疗决定。通过支气管镜的导航遵循基于术前CT扫描和从术前CT扫描创建的肺部模型以常规方式到达近似目标组织位置。用户操纵导管,并且使用电磁(EM)导航通过在监视器上对呈现给医师的模型图像空间中的肺部组织进行可视化来接近目标组织位置。来自导航系统的位置信息向医师显示了他在衍生的肺部模型中的位置。然后使用超声(US)成像来限定关注的组织的第一目标平面或第一目标体积及其精确位置。接下来,用户定义包含均质组织样本的该目标体积的减小版本。选择该第二减小的目标平面或减小的目标体积,以便排除不相关的解剖结构并产生表示可疑肿瘤组织的均质样本的图像平面或图像体积。通过实施QUS技术使用相当于声学活检的数量评估第二减少的目标。整个导管系统允许放置物理活检采样工具。然后将该工具(例如针或刷子)放置在声学评估的相同目标点处,并且使从相同组织(诸如淋巴结或其他关注的目标组织等)获得的组织样本经受声学活检。
如上所述,超声系统具有两种操作模式。第一成像模式和第二定量频谱评估模式,第一成像模式以切片方式显示相对大的第一目标区域,第二定量频谱评估模式从第二减小的目标区域选择反向散射辐射。
超声成像系统提供导管远侧尖端周围的受控视图。超声换能器的优选实施例是固定在导管的远侧尖端内的位置中的平面阵列。平面阵列可以以合成孔径模式使用,该合成孔径模式构造显示图像平面,该显示图像平面由在导管主体静止时多次在多个位置获取的数据形成。可以将导管从第一位置平移到第二附近位置。导管运动可单独使用以排除来自第二减小的目标区的解剖结构。导管的运动产生了用于图像收缩或反向散射评估的扫掠体积。
通常,超声换能器的视场将是60度或更小,但如以上所建议的,该超声换能器可以被机械地或电子操纵地旋转或平移以控制该视场的大小。与典型的EBUS系统相比,视野的深度或范围也可受到限制,在典型的EBUS系统中,需要大视角的广泛组织。通常,US视图将包括几种组织类型。医学判断用于调整和定位目标组织附近的导管系统,以将用于声学活检的关注的目标组织与其他解剖学特征(诸如血管和类似物等)隔离开。以此方式,医学专家学会选择涵盖可疑肿瘤组织的第一目标区。接下来,选择初始第一目标体积的子集用于反向散射分析。该第二减小的目标区将被选择为没有外来的解剖结构并且提供相对均质的组织样本以提供适合于频谱评估的反向散射。
通过EM导航系统的EM位置部分注意到声学活检的位置,可以将整合的活检样本装置引导至声学活检位置。这种针尖放置可以以非常高的精度完成,因为它是通过来自EM传感器4D的位置信息的知识来计算的。
因此,并且在实践中,US系统用于对被称为第一目标区的组织体积进行成像,并且然后操作者操纵导管系统以隔离第二减小的目标区,从而在超声传感器操作的定量模式的较小视场内包含关注的组织。在组织分离的情况下,声学反向散射辐射被评估以辨别组织的性质。通过使用QUS工具,非常小的样本有效地经受“声学活检”或“声波活检”,该“声学活检”或“声波活检”在原位进行,并且在需要时可以重新访问以提供治疗的已知位置。
此外,QUS可以用于分析肿瘤基质和微脉管系统性质,以提供与细胞死亡和/或凋亡相关的参数,从而提供疗法(诸如化学疗法、近距离放射疗法、细胞毒性剂(药物)疗法或消融疗法等)的确认或监测数据。这种分析可以使用参数(诸如有效散射直径和有效声学浓度等)提供肿瘤对治疗的反应的临时反馈。可以通过评估来自多个不同方向的结节并确定超声信号的穿透深度来分析肿瘤或组织硬度的异质性。
具有创建结节的3D或4D超声图像的能力。用户能够计算3D或4D图像的非纹理参数和纹理参数两者。可以在超声空间中定义非纹理特征,诸如尺寸、形状和相对于相邻结构(胸膜、裂缝、血管等)的位置描述等。另外,基于纹理的特征(诸如像素强度直方图和游程长度(连续类似的灰度级或RF级)和共现)以定义精细到粗糙组织的度量。诸如对比度、能量、均质性、熵、均值和最大概率等的共现度量可以用于表征结节中的组织。图像可以在正交分量中分解以提供这些图像的小波特征。可应用内核来反映或突出图像中的特定或不同类型的结构。基于多个取向应用多个内核可用于表征结节的组织。AI技术可以用于增强图像域中的基于纹理的分类。
示例性US系统使用利用现代微加工技术制造的压电换能器。通常,各个换能器元件的阵列是可寻址的,并且可以被单独激活。通常,阵列将包括被定尺寸成操作特定谐振频率的元件。尽管单个频率阵列是可能的,但预期阵列将具有至少两个频率可操作的元件。这些元件可以被认为具有有时被称为鼓尺寸的直径和深度,并且像鼓一样,每个元件将具有与其几何形状相关联的共振频率。通常,存在用于生产包括基于PZT(压电换能器)、pMUT(压电式微加工超声换能器)或cMUT(电容式微加工超声换能器)的装置的超声换能器阵列的许多制造替代方案。预期这些方案中的任何一种可以用于收集组织信息。需要考虑权衡,并且期望最大化装置的部分带宽。针对不同组织类型具有共同或一致的表征可以通过换能器的已知性能特性的校准来实现,或使用从集成电路(诸如pMUT等)提供的可重复性能来实现。这种标准化是提供组织的可重复识别的关键。该系统可以允许改变超声换能器的频率并且因此以多个频率(4至50MHz)捕获组织数据。成像可优化为20MHz,而声学活检可在通常更高的不同频率下获取。
当前的US系统具有在横向方向上降低分辨率的限制,这根据关注组织距超声换能器的距离而产生变化的信号。超声换能器的阵列结构可为整个视场(FOV)或在遍及换能器变化的深度上在横向方向上提供更高的、一致的分辨率。
具有集成的EM定位的US系统允许通过记录多个超声图像平面并且重构体积来收集3D和4D超声体积。这些体积可以被呼吸门控以具有在相同的关注组织位置处创建多个体积(即,潮气量吸气、潮气量呼气或沿着呼吸周期的过渡状态)。这些体积可以处于从原始电信号数据到波束形成的B模式图像数据的多个处理状态以用于分析。
集成的EM传感器允许从多个视点或角度对同一关注的组织进行采样,从而基于视点来确定变化或改变。避免诸如血管、裂缝或周围感染的结构等将提供更清洁的声学活检,并且可以用于基于来自其他结构的干扰来确定所收集的声学活检的质量。
为了使超声换能器尽可能接近关注的组织,重要的是将装置小型化至直径小于2mm,并且尽可能短以便进行紧密的转弯,从而保持导管通过患者气道的柔性。在支气管内的实施例中,目前设想具有至少64个成像元件,但是从16至超过256的其他配置可以是可操作的。这些多个成像元件被多路复用以允许尽可能少的电线来驱动US换能器,同时保持20至30帧/秒的帧速率。
使用EM系统和已注册的CT数据,提供了相关的多个模态图像,这些图像可以用于增强解释。可以注册其他的模态(诸如PET-CT等)以识别关注的组织。超声图像提供可用于手术前或手术中图像变形的除EM系统以外的附加数据点。不仅可以将路径记录为点云,而且可以将气道外部的路径体积收集为点云的一部分。
使用临床概况、人口统计学和成像数据(CT、FDG-PET(扫描术)、生长速率)来估计具有肺部结节的患者中恶性肿瘤的概率的模型(诸如Gurney、梅约诊所(Mayo Clinic)、Herder、VA、北京大学人民医院、布鲁克大学、胸部研究评估与治疗(Thoracic ResearchEvaluation and Treatment)以及贝叶斯推理恶性计算器等)是熟知的。虽然它们确实提供了医师的意见,但它们不足以明确地确定结节是否是恶性的。此外,放射学已经被应用于CT图像以进一步基于CT图像数据提供恶性肿瘤的可能性。这种具有集成EM能力的US系统使得能够将CT和FDG-PET图像数据配准至患者并且使US、CT和FDG-PET图像数据在患者内的精确位置处同时相关联。另外,通过红外线、紫外线和可见光创建支气管镜图像数据(组织的颜色变化)。还可以集成压力传感器以提供用于关注的组织的压力数据。另一种类型的传感器可以包括在装置中,例如,温度传感器可以被集成以确定组织与关注的组织区之间的温度变化。氧传感器可以被集成以确定组织之间的氧水平的变化。可以使用其他类型的传感器来监测组织的代谢特征。该额外的传感器值可用于帮助确定癌症的存在。
应当理解,这个装置不限于肺部并且可以用于多个器官(肺、肝、肾、前列腺、软组织、胰腺等)。到达关注组织的途径可以是气道或血管或直接经皮通路或通过自然孔口的通路。它还可以用于治疗确认以及结节诊断。
附图说明
图1是本发明的背景的示意图;
图2是导管系统的近侧部分的示意图;
图3是导管系统的远侧部分的示意图;
图4A是在导管的远侧尖端附近截取的横截面的示意图;
图4B是导管主体的区段的详细部分:
图5是系统的电子分配的示意性框图;
图6是示出第一目标图像平面的示意图;
图7是示出减小的第二目标图像平面的示意图;
图8是示出用于QUS的说明性声学参数的频谱图。
具体实施方式
转向图1,未看到的患者正在经历通过镜体10的支气管内干预。图2和图3中更详细示出的导管组件14包括细长导管主体18,该细长导管主体18终止于远侧或尖端16并从近侧夹持器20延伸穿过手柄12。该组件用手柄12和由旋转构件15操纵。组件14进而被插入到镜体10的工作通道17中。注意,手柄能够与镜体10独立地移动,并且可以通过在镜体10静止的状态下操作旋转构件15来实现如图中旋转箭头13所示的旋转运动。以此方式,导管系统14经由镜体10被导航到肺部(未示出)中。医师可以经由镜体10和近侧夹持器20和手柄12操纵导管系统。
图3单独且更详细地示出了导管主体18的远侧尖端16。如图2所示,导管主体18延伸穿过手柄12,并且可以用导管的近侧夹持器20在足以允许缩回到镜体的远端中并对传感器实现小运动的小范围上进行调节。组件14在镜体10内的总长度和定位(以适应镜体长度)通过伸缩延伸件24来执行,而导管位置的小平移通过手柄12和近侧夹持器20来执行。导管主体18的远侧主体承载进入内腔,该进入内腔可用于引入工具,诸如针26等,该工具示出为从主体18中的孔露出。
图4A示出了远离孔的远侧尖端的横截面。多元件平面超声阵列30位于导管主体18内,平行于导管的纵向轴线21定位(在图1和图3中示出)并且由透镜32覆盖。电子封装34位于靠近如线圈38和线圈36所示的EM线圈的尖端。其他封装策略也可以证明是可操作的。
图4B示出了细长导管主体18的一部分,该部分可由不锈钢或其他材料形成,并且为了产生和控制其柔性,管状结构可被激光切割成允许在一个或更多个平面中的柔性的螺旋图案。这些激光切割的切口19被定向成允许弯曲。
图5是导管系统及其伴随成像系统的电子部件的分区,并且是该系统在其当前实施方式中的说明性但非限制性版本。
图4的电子封装34除其他外将包含用于配置阵列30的可编程芯片。多路复用器将数据格式化并将数据从导管系统传输到患者接口模块或PIM42,患者接口模块或PIM42将悬挂在与患者一起的轮床上的床边。PIM42包括用于保护患者的电隔离并且还包含用于导管自身的电源,在PIM中完成A/D转换和各种缓冲过程以改善导管的噪声性能。在这个实施方式中,单独的“比萨盒”外壳承载用于合成孔径波束形成和控制以及用于QUS过程44的反向散射信号的频谱分析的专用硬件。外壳耦接到基于工作站的导航和显示推车。驻留在比萨盒外壳中的QUS反向散射评估系统44可以是单独的或者结合到工作站46本身中,在工作站46本身中展示超声信号和分析的可视图像。
如在别处简要描述的,导管主体18承载使用微加工技术制造为阵列30的可单独寻址的压电换能器或元件的矩阵。阵列的每个元件(图4A中示为元件31和33)可被供电以发射作为从特定换能器位置发出的球面波的超声能量,并且阵列中的每个元件可用作将反向散射声音的机械能转换成电信号的接收器。一旦球面波从给定元件31发射,伴随换能器(诸如元件33等)就可以在延迟之后检测从生物组织反射的反向散射能量。在合成孔径的情况下,一次只有一个换能器33正在监听发射换能器31元件。
通常,元件对将被激活,其中一个元件31用作声能的发射器并且伴随元件33用作接收器。由于元件在空间中排列,所以阵列中存在多个视点。当与现有技术方法相比时,这提供了大大改进的横向分辨率。
利用存储的数据,阵列中的下一个换能器被激活以发射声能,并且其互补换能器接收反向散射的返回信号。在许多(例如64个)换能器在不同位置处,来自所有位置的所有返回能量的合成可用于通过计算正交于换能器的平面的图像平面来形成。
可以一次使多于一个换能器对活动,并且在示例性实施例中,同步收集4个数据通道。这些限制基于数据路径的复杂性、功率消耗和带宽。因此,在权利要求的范围内其他配置是可能的并且是预期的。用于在平面中从在空间中的各个点处发射和接收的时间排序的多路复用数据中提取图像的数学是复杂的,但是在本领域中是众所周知的和理解的。通常,所展示的图像平面是从在不同时间获取的空间中的许多位置处获取的数据合成的,这些数据被共同地卷积成单个图像平面,因此称为合成孔径。如果沿着路径移动导管,则合成孔径图像平面扫出一定体积。这是组织体积的相对低分辨率的图像,但是可以帮助解析解剖的程度,以补充对2D第一图像平面区中的解剖结构(诸如气道、血管等)的检测。在这点上,本发明的方法可以依赖于平面中的第一目标图像区,或者依赖于称为第一目标图像体积的3D体积。在后一种情况下,导管运动用于限定目标组织的第一3D体积。
在使用中,超声换能器阵列存在两种操作模式。在第一模式中,来自反向散射的声能的振幅和包络信息被用于形成呈现给临床医师的图像。这可以是目标组织的第一2D切片或目标组织的3D体积。在第二模式中,降低发射功率以在第一图像平面或图像体积内选择较小的目标平面或体积。在2D切片的情况下,该减小视图被称为第二减小区或切片,或者在3D体积的情况下,该减小视图被称为第二减小体积。在每种情况下,减小视图被选择为没有第一视图中观察到的解剖细节。总体解剖结构的排除选择用于定量分析的均质样本。定量地和自动地评估来自减小区切片或体积的反向散射能量的频谱,而不是用于形成图像。无图像的定量信息被用于确定减小的组织区是否展现癌变组织的声学特性。癌症的精确特征或声学是当前研究的主题。
图6示出了具有位于图中标记为60的位置“1”处的远侧尖端的导管主体18。在光影图中示出的第一目标平面62是与位于气道66附近的可疑肿瘤块64相交并且被图中标记为68的血管穿过两次的图像平面。该图像模式超声数据用于找到可疑肿瘤块并验证和记录其位置。为了帮助定位和识别可疑肿瘤块,导管主体18可沿着轴向路径11平移或如旋转路径13所示经由旋转构件15旋转,如图1所示。
图7示出了略微重新定位或移动的导管主体18,使得与减小的目标平面72相关联的反向散射体不与血管或气道相交。这是用于QUS的反向散射评估的减小的第二图像平面。注意,导管的运动可以由医师做出,或者可以激活阵列的不同部分以实现相同的效果。通常,自动化系统将从第一目标平面中的初始图像中选择减小的目标区。自动化系统可形成图5的元件44中所示的OUS系统的一部分。通常,该过程将基于连续性和对比度来排除图像分量以自动移除例如血管和气道。阵列中的换能器的功率电平可以被定制为在自动过程中切出图像的部分,或者图像平面可以在不同的位置中被合成以排除检测到的解剖细节。最终目标是提供完全基于US信息的自动评估的建议或诊断。
图8示出了Y轴上的归一化反射声功率和X轴上的对应频率的频谱图。以正方形100为代表的正方形描绘了在对应频率下的反射功率的振幅。可以通过由数据点100代表的不同数据绘制“最佳拟合”线102。这条线的斜率是有用的参数并且在104处在该图上被标识。最佳拟合线102与y轴相交的点是Y截距88。如果排除了定义中频带的高频率和低频率两者,则剩余值的算术平均值形成图中所示的中频带拟合值86。
校准和替代实施例。
通常,超声频谱将被归一化以执行QUS参数。然而,反射信号中的绝对能量仅具有诊断值,并且预期临床上也将使用未归一化的频谱。为此,尤其重要的是校准单个的导管传感器。超声换能器技术以及制造方法导致广泛变化的灵敏度和其他声学特性。可以预期的是,每个传感器将在制造过程中被表征为在传感器的整个操作范围内生成传感器的补偿轮廓。这个独特的校准表将存储在导管上,这是适当的读取存储器。
通常优选的是具有线性平面US换能器阵列以执行本发明的步骤,然而,作为替代方案,传感器可以是形成饼状视场的线性结构。而且,这个饼形视场可以机械地通过旋转运动13或者电子地围绕圆步进。
可以在手柄中调整附加的EM传感器的节奏,并且该近侧EM传感器系统可以与远侧尖端中的EM传感器阵列一起使用,以平移影响传感器的医师运动,从而向医师提供关于导管系统的取向的信息和反馈。在这个版本中,这两个EM传感器的相对运动或位置以及导管的已知几何形状允许计算尖端的位置或导管的另一属性。
在另一个实施例中,公开了一种使用本文描述的医疗装置使患者体内的区域成像的方法。该方法包括以下步骤:
提供如图1所示的导管组件14。导管14具有细长导管主体18,细长导管主体18包括一起形成的导管组件14的近侧手柄部分12和远侧尖端部分16。如在图4A中看到的,存在位于远侧尖端部分16内的至少两个电磁感测线圈36和38。返回到图1,图1示出了导管组件14适于穿过支气管镜10的工作通道17使用,以便提供通向患者的肺部或其他组织的通路。
如图4A中所示并且在图6和图7中进一步示出的,多元件平面超声波换能器阵列30位于导管组件14的远侧尖端部分16内。阵列30被配置成用于超声波能量的发射和接收。阵列30在导管尖端部分16处平行于所述导管主体18的轴线21定位。
如图5至图7所示,医疗装置系统进一步设置有成像系统,该成像系统耦接至所述超声换能器阵列30,用于在第一目标平面62中产生组织的图像,第一目标平面62从所述导管主体18正交地延伸。提供反向散射评估系统44以接收并评估位于从第一目标平面62中选择的第二减小的第二目标区72中的组织的声谱特性。
医疗装置的远侧尖端被导航到第一位置,诸如以图6所示的方式等。在此,诸如以如图6和图7中所示的方式等在第一目标平面和所述第二减小的目标区中观察组织。分析在所述第二目标区内观察到的组织的声谱。在所述第二减小的目标区内将诸如针26等的取样工具部署到例如淋巴结这样的目标组织。
图6-图8所示的超声图像数据、声谱表征数据和位置数据全部在相同的时间和相同的位置被采集并被展示给医师以告知医疗决定。
可替代地,诊断患者的肺部组织内的关注区域的方法包括以下步骤:
将图1中所示类型的导管14穿过支气管镜工作通道17以进入所述肺部组织。导管包括细长导管主体18,细长导管主体18包括轴线21和远侧尖端部分16。至少两个电磁感应线圈36和38位于所述远侧尖端部分内,如图4A所示。同样定位在远侧尖端部分16中的是多元件平面超声换能器阵列30。平面阵列30平行于所述导管主体的轴线21定位。如图6所示,使用与两个电磁感应线圈36和38相互作用的导航系统46将导管18的远侧尖端部分16导航至接近关注区域的第一位置。接着系统经由阵列30将第一超声能量发射到图6中所示的所关注区域中。阵列30接收第一超声能量并且将其传输到成像系统46。
在成像系统处,创建图6中所示的关注区域的图像。该图像将显示解剖结构,所述解剖结构选自包括气道和血管的一组结构。然后,系统识别不包含解剖结构的关注区域的图像内的目标区。
使用所述导航系统将远侧尖端移动至靠近目标区的第二位置。随后阵列30将第二超声能量信号发射到目标区中,且使用图5中示出的反向散射评估系统44评估返回信号。在反向散射评估系统处,评估接收的第二超声能量的声谱以提取关注区域的目标区的诊断信息。
从以上描述中,本发明的许多特征和优点是明显的。本领域的技术人员将容易想到许多修改和变型。因为这些修改是可能的,所以本发明不限于所示出的和所描述的精确构造和操作。相反,本发明应仅由所附权利要求书限制。
Claims (7)
1.一种医疗装置系统,包括:
a)导管,所述导管具有细长导管主体,所述细长导管主体包括近侧手柄部分和远侧尖端部分,所述近侧手柄部分和所述远侧尖端部分一起形成导管组件,所述导管组件被适于穿过支气管镜工作通道使用,所述支气管镜工作通道提供到患者的肺组织的通路,
b)至少两个电磁感应线圈,所述至少两个电磁感应线圈位于所述远侧尖端部分内;
c)多元件平面超声波换能器阵列,所述多元件平面超声波换能器阵列位于所述远侧尖端部分内,并且用于发射和接收超声波能量,所述平面超声波换能器阵列在所述导管尖端部分处平行于所述导管主体的轴线定位;
d)成像系统,所述成像系统耦接到所述超声波换能器,并且用于在从所述导管主体正交延伸的第一目标平面中创建组织的图像;
e)反向散射评估系统,所述反向散射评估系统用于接收和评估位于从所述第一目标区中选择的第二减小的目标区中的组织的声谱特性。
2.根据权利要求1所述的医疗装置,其中包含所述多元件平面超声波换能器阵列的所述远侧尖端的区域包括声透镜。
3.根据权利要求1所述的医疗装置,进一步包括:
取样系统,所述取样系统位于所述远侧尖端附近,并且与所述超声波换能器同心。
4.根据权利要求2所述的医疗装置,其中,所述取样系统是针,所述针通过孔从所述导管主体内部署。
5.一种使用医疗装置系统对患者体内的区域成像的方法,所述方法包括以下步骤:
a)提供所述医疗装置系统,所述医疗装置系统包括:
i)导管组件,所述导管组件具有细长导管主体,所述细长导管主体包括近侧手柄部分和远侧尖端部分;
ii)至少两个电磁感应线圈,所述至少两个电磁感应线圈位于所述远侧尖端部分内;
iii)所述导管组件被适配成穿过支气管镜工作通道使用,所述支气管镜工作通道提供到患者的肺组织的通路;
iv)多元件平面超声波换能器阵列,所述多元件平面超声波换能器阵列位于所述远侧尖端部分内,并且用于发射和接收超声波能量,所述平面超声波换能器阵列在所述导管尖端部分处平行于所述导管主体的轴线定位;
v)成像系统,所述成像系统耦接到所述平面超声波换能器阵列,并且用于创建在从所述导管主体正交延伸的第一目标平面内的组织的图像;
vi)反向散射评估系统,所述反向散射评估系统用于接收和评估位于从所述第一目标平面选择的第二减小的目标区中的组织的声谱特性;
b)将所述导管主体的远侧尖端部分导航到第一位置;
c)用所述第一目标平面和所述第二减小的目标区观察组织;
d)评估所述第二减小的目标区内的组织的声谱;
e)将取样工具部署到所述第二减小的目标区内的位置;
f)向医师提供全部在相同时间和相同位置采集的超声波图像数据、声谱特征数据和位置数据以告知医疗决定。
6.一种诊断患者的肺组织内的关注区域的方法,包括以下步骤:
a)使导管穿过支气管镜工作通道以进入所述肺组织,所述导管包括:
i)细长导管主体,所述细长导管主体包括轴线和远侧尖端部分,
ii)至少两个电磁感应线圈,所述至少两个电磁感应线圈位于所述远侧尖端部分内,以及
iii)多元件平面超声波换能器阵列,所述多元件平面超声波换能器阵列位于所述远侧尖端部分内,所述平面阵列平行于所述导管主体的轴线定位;
b)使用与两个电磁感应线圈相互作用的导航系统将所述导管的所述远侧尖端导航至接近所述关注区域的第一位置;
c)将第一超声波能量发射到所述关注区域中;
d)在成像系统处从所述换能器阵列接收所述第一超声波能量;
e)在所述成像系统处,创建所述关注区域的图像,所述图像示出解剖结构,所述解剖结构选自包括气道和血管的一组结构;
f)识别所述关注区域的图像内的不包含所述解剖结构的目标区;
g)使用所述导航系统将所述导管的所述远侧尖端移动到靠近所述目标区的第二位置;
h)将第二超声波能量从所述换能器阵列发射到所述目标区中;
i)在反向散射评估系统处从所述换能器阵列接收所述第二超声波能量;
j)在所述反向散射评估系统处,评估所述接收的第二超声波能量的声谱以提取所述关注区域的目标区的诊断信息。
7.根据权利要求6所述的方法,进一步包括:
k)将取样工具部署到所述第二目标区内的位置。
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